# K962041: Acs LH2 Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Corning Diagnostics Corp.
- Decided: Jun 21, 1996 after 24 days
- Product code: CEP (Radioimmunoassay, Luteinizing Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1485
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910198 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910198: Ciba Corning Acs LH Immunoassay, Ciba Corning Diagnostics Corp. (1991) Summary page 1.

## Most influential descendants
- K101460: Loci 8 Calibrator, Model KC 646 (2010), 0 descendants of its own

## Indications for use
The intended use of ACS LH2 is for the quantitative determination of LH in serum using the Ciba Corning Automated Chemiluminescence Systems.

Source page: https://510kreport.com/device/K962041
Methodology: https://510kreport.com/methodology